EP3717048A1

EP3717048A1 - Device for inhalation-synchronised dispensing of a fluid product

Info

Publication number: EP3717048A1
Application number: EP18830906.6A
Authority: EP
Inventors: Ludovic Petit
Original assignee: Aptar France SAS
Current assignee: Aptar France SAS
Priority date: 2017-11-29
Filing date: 2018-11-26
Publication date: 2020-10-07
Anticipated expiration: 2038-11-26
Also published as: FR3074051A1; WO2019106270A1; EP3717048B1; CN111405920A; JP2021504056A; FR3074051B1; CN111405920B; US11865249B2; JP7212043B2; US20200282160A1

Abstract

A device for inhalation-synchronised dispensing of a fluid product, comprising a body (10) provided with a mouthpiece (400), a reservoir (100) containing a fluid product and a propellant gas being axially mounted so as to slide in said body (10), a metering valve (200) being assembled on said reservoir (100) in order to selectively dispense the fluid product, said device comprising an immobilising element (500) which can be moved and/or deformed between a non-actuating position, in which said metering valve (200) cannot be actuated, and an actuating position, in which said metering valve (200) can be actuated, and a triggering system controlled by inhalation, comprising an inhalation-sensitive member (60) that can be deformed and/or moved under the effect of inhalation, said inhalation-sensitive member (60), when it deforms and/or moves, moving and/or deforming said actuating element (500) from its non-actuating position to its actuating position, said device comprising an actuator (20) attached on said reservoir (100), said actuator (20) comprising a proximal wall (22) that is fixed, in particular force-fitted, on the bottom of the reservoir (100), a body (23) sliding axially around said proximal wall (22), and a spring (21) arranged between said proximal wall (22) and a distal wall (24) of said body (23), said body (23) sliding axially around said proximal wall (22) between a rest position and a loaded position, in which said spring (21) is compressed, such that after actuating said triggering system controlled by inhalation, said compressed spring (21) axially moves said reservoir (100) in said body (10) in order to actuate said metering valve (200).

Description

Device for dispensing fluid product synchronized with the inhalation

The present invention relates to a fluid dispensing device synchronized with inhalation, and more particularly to an inhalation device of the aerosol type synchronized with the inhalation.

Inhaling devices generally referred to as B.A.I. (meaning "Breath Actuated Inhaler"), are well known in the state of the art. The main advantage of this type of device is that the distribution of the product is synchronized with the inhalation of the patient, to ensure a good distribution of the product in the airways. Thus, in the field of aerosol devices, that is to say those in which the product is distributed using a propellant, many types of devices for triggering by inhalation have been proposed. However, these devices have the disadvantage of having a large number of parts, that is to say, they are complicated and expensive to manufacture and assemble, which is obviously disadvantageous. It is also difficult to find the right balance between reliable triggering at each inhalation, without the triggering threshold being too high, and a lock robust enough to prevent accidental or unwanted actuation. However, if the lock unlocks accidentally, the device is operated automatically and the dose is distributed, even if the user did not want it.

Thus, more than the automatic actuation of the device, what is important to obtain a good distribution of the dose is to achieve this distribution in a manner synchronized with the inhalation of the user, even if the actuation or triggering itself remains manual.

FR2775668, WO2017178764, WO2017178765 and

WO2017178768 disclose devices of the state of the art.

A disadvantage of these devices lies in the risk of blockage if the actuating force of the user is too great, that is to say if it exerts on the bottom of the tank an axial force of too strong actuation . The object of the present invention is to provide a fluid dispensing device synchronized with the inhalation which does not reproduce the aforementioned drawbacks.

The present invention also aims to provide a fluid dispenser device synchronized with inhalation which improves operating reliability, ensuring effective actuation with each inhalation, without risk of blockage.

The present invention also aims to provide a fluid dispenser device synchronized with the inhalation which minimizes the risk of accidental or unwanted actuation.

It is another object of the present invention to provide a fluid delivery device synchronized with the inhalation which does not have an excessively high triggering threshold, thus enabling relatively weak persons, such as sick or elderly persons, to use the device safely and reliably.

The present invention also aims to provide a device for dispensing fluid synchronized with inhalation that is simple and inexpensive to manufacture and assemble.

The subject of the present invention is therefore a fluid dispensing device synchronized with inhalation, comprising a body provided with a mouthpiece, a product reservoir containing a fluid product and a propellant gas being mounted axially sliding in said body, a metering valve comprising a valve being assembled on said reservoir for selectively dispensing the fluid, said device comprising:

a movable and / or deformable locking element between a non-actuating position, in which said metering valve can not be actuated, and an actuating position, in which said metering valve can be actuated, said locking element, in non-actuating position, cooperating on the one hand with the body and on the other hand with the reservoir to prevent axial displacement of said reservoir in the body, and an inhalation-controlled triggering system comprising an organ sensitive to inhalation deformable and / or movable under the effect of inhalation, said member sensitive to inhalation, when it deforms and / or moves, displacing and / or deforming said actuating element from its non-actuating position to its actuating position,

said device comprising an actuator fixed on said reservoir, said actuator comprising a fixed proximal wall, in particular force-fitted, on the bottom of the reservoir, a body sliding axially around said proximal wall, and a spring disposed between said proximal wall and a wall distal from said body, said body sliding axially around said proximal wall between a rest position and a loaded position, wherein said spring is compressed, so that after actuation of said triggering system controlled by inhalation, said compressed spring moves axially said reservoir in said body for actuating said metering valve.

Advantageously, said locking element is a fixed locking ring, in particular latched, on said reservoir and having at least one axial lug, in particular three, cooperating with a shoulder integral with said body to block the axial displacement of said reservoir in said body.

Advantageously, said at least one axial tab is deformable radially outwardly to move from the non-actuating position to the actuating position, a trigger element being provided to maintain said at least one axial tab in the non-actuating position.

Advantageously, said trigger element is movably mounted between a locking position, in which it blocks said locking element in its non-actuating position, and a release position, in which it does not block said locking element.

Advantageously, said member sensitive to inhalation of said triggering system controlled by inhalation comprises a deformable membrane defining a deformable air chamber, said deformable membrane being fixed to said trigger element, said deformable membrane being deformed during the inhalation of such that it moves said trigger member from its locking position to its release position.

Advantageously, said spring is a coil spring. Alternatively, said spring may be a plastic spring.

Alternatively, said spring may be a foam member.

Advantageously, said actuator comprises a radial flange extending radially outwardly on either side of said body.

Advantageously, the rest position of said actuator is defined by an axial abutment formed between a lower axial edge of said proximal wall and an internal radial shoulder of said body.

Advantageously, the loaded position of said actuator is defined by an axial abutment formed between a lower axial edge of said body and an upper axial edge of an inner sleeve integral with said body.

These and other features and advantages will appear more clearly in the following detailed description, with reference to the accompanying drawings, given as non-limiting examples, and in which:

FIG. 1 is a diagrammatic cross-sectional view of a fluid dispensing device, in the rest position,

FIG. 2 is a view similar to that of FIG. 1, in position of non-distribution before aspiration,

FIG. 3 is an enlarged view of detail A of FIG. 2,

FIG. 4 is an enlarged view of detail B of FIG. 2,

FIG. 5 is a view similar to that of FIG. 2, in position after aspiration,

FIG. 6 is a view similar to that of FIG. 5, in the dispensing position of a dose of fluid product,

FIG. 7 is an enlarged detail view of part of FIG. 1; FIG. 8 is a schematic perspective view of the actuator of FIG. 1;

FIG. 9 is a schematic view from above of the actuator of FIG. 1,

FIG. 10 is a diagrammatic cross-sectional view of the actuator of FIG. 1, and

- Figure 11 is a view similar to that of Figure 10, illustrating an alternative embodiment. In the description, the terms "upper", "lower", "high" and "low" refer to the position of the device shown in particular in FIG. 1. The terms "axial" and "radial" refer to the axis vertical central X shown in particular in Figure 1. The terms "proximal" and "distal" refer to the mouthpiece.

The invention is more particularly applicable to aerosol valve type inhalation devices for oral delivery, as will be described in more detail below, but it could also be applicable to other types of devices. inhalation, for example of the nasal type

The figures represent an advantageous embodiment of the invention, but it is understood that one or more of the constituent parts described below may be performed differently while providing similar or identical functions.

With reference to the drawings, the device comprises a main body 10 provided with a mouthpiece 400. This mouthpiece 400 defines a dispensing orifice through which the user will inhale during use of the device. A removable protective cover 410 may be provided on said mouthpiece 400, especially during storage periods, that the user will remove before use. Figure 1 shows such a protective cover, which could be of any shape.

An inner sleeve 800 may be provided inside said body 10, as shown in the figures.

The body 10 contains a reservoir 100, containing the product to be dispensed and a propellant, such as an HFA type gas, a metering valve 200 being mounted on said reservoir 100 to selectively distribute the product. The metering valve 200 comprises a valve body 201 and a valve 210 axially displaceable upon actuation with respect to said valve body 201, and thus with respect to said tank 100. This metering valve 200 may be of any suitable type. It can be fixed to the reservoir 100 by a fixing element, preferably a crimped capsule 5, preferably with the interposition of a neck seal 4. Advantageously, during actuation, the valve 210 is fixed relative to the body 10, and it is the reservoir 100 which is displaced axially relative to the body 10 between a distal position, which is the rest position, and a position proximal. In the example of the figures, the reservoir slides axially inside said inner sleeve 800.

The outlet port of the valve 210 of said metering valve 200 is connected via a channel 300 to said mouthpiece 400, through which the user inhales the dispensed product. In known manner, said valve 210 is received in a valve well 700 which at least partially defines said channel 300. The valve well 700 can be formed integrally with the body 10, or, as in the example shown, be formed by a piece assembled on said body 10.

According to the invention, the device comprises an actuator 20. This actuator 20 is mounted, in particular force-fitted, on the bottom of the reservoir 100 and comprises a spring 21 adapted to be compressed when the user presses axially on said actuator 20. spring 21 may be a conventional coil spring, as shown in particular in Figure 10, or alternatively a plastic spring or a foam member, as shown in Figure 11. This actuator 20 ensures an actuating force of the valve 200 perfectly controlled, reproducible and independent of the actuation force achieved by the user. It is always the compressed spring 21 which moves the reservoir 100 axially to actuate the valve 200. This makes it possible in particular to avoid any risk of blockage which could occur in the event of excessive actuation force by the user.

As can be seen in particular in FIGS. 10 and 11, the actuator 20 comprises a fixed proximal wall 22, in particular force-fitted, on the bottom of the reservoir 100, and a body 23 sliding axially around said proximal wall 22, with the spring 21 disposed between said proximal wall 22 and a distal wall 24 of said body 23. Said body 23 slides axially around said proximal wall 22 on the one hand between a rest position, visible in Figures 1, 10 and 11, and a position loaded , visible in Figures 2 and 5, wherein the spring 21 is compressed to the maximum. On the other hand, said body 23 slides axially around said proximal wall 22 between said loaded position and an actuated position, visible in FIG. 6, in which the spring 21 has transmitted its force to move the reservoir 100 in the body 10 to actuate the valve 200.

Advantageously, the actuator 20 may comprise a radial flange 25 extending radially outwardly on either side of the body 23, allowing easy axial support for the user. Of course, this radial flange 25 is not mandatory and the axial support of the user can also be done on said distal wall 24 of the body 23.

In the example shown in the figures, the rest position of the actuator 20 is advantageously defined by an axial abutment formed between a lower axial edge 29 of said proximal wall 22 and an internal radial shoulder 26 of the body 23. The loaded position is advantageously defined by an axial abutment formed between a lower axial edge 27 of the body 23 and an upper axial edge 801 of the inner sleeve 800. In a variant, this axial abutment of the loaded position could also be formed with an upper axial edge of the body 10 .

The device comprises a blocking element 500 displaceable and / or deformable between a non-actuating position, in which said metering valve 200 can not be actuated, and an actuating position, in which said metering valve 200 can be actuated. In the rest position, said locking element 500 is in the non-actuating position, and it is the inhalation of the user through the mouthpiece 400 which moves and / or deforms said locking element 500 towards its position d actuation. In other words, as long as the user has not inhaled, the actuation of the metering valve 200 is impossible, and it is only when he inhales that said metering valve 200 can be actuated.

As will be described in more detail below, the blocking element 500, in the non-actuating position, prevents axial displacement of the reservoir 100 in the body 10. Upon inhalation, this locking element 500 is displaced and / or deformed so that it no longer blocks the axial displacement of the reservoir 100 in the body 10. Thus, after inhalation, such axial displacement of the reservoir 100 causes the actuation of the metering valve 200 and the distribution of a product dose synchronized with this inhalation.

Thus, in the absence of inhalation, there is no risk that a dose of active product is lost by an unfortunate or incomplete operation in which the user would not exert inhalation. The actuation of the valve 200 and the expulsion of a dose of fluid product are therefore possible only if the user inhales and simultaneously the reservoir 100 moves in the body 10 to actuate the valve 200.

The device comprises a triggering system controlled by the inhalation of the user, which is intended to move and / or deform said locking element 500 from its non-operating position to its actuating position, when the user inhales at through the mouthpiece 400.

This triggering system comprises an inhalation sensitive member 60 that is deformable and / or displaceable under the effect of the inhalation, this inhalation-sensitive member 60 being adapted, when it deforms and / or moves, to moving and / or deforming said locking element 500 from its non-operating position to its actuating position.

As will be described in more detail below, the inhalation sensitive member 60 may be embodied as a deformable air chamber, for example a bellows or a deformable pocket.

Advantageously, the non-actuating position corresponds to a blocking position of the reservoir 100 in the body 10. In this blocking position, the reservoir 100 is prevented from moving by said blocking element 500, which will be released only at the moment inhalation.

The locking element 500 is advantageously formed by a locking ring, comprising at least one, preferably three axial locking tabs 501, which are elastically deformable radially outwardly. This locking ring is fixed, in particular snapped, on the reservoir 100, in particular on the capsule 5 which fixes the metering valve 200 on the reservoir 100. The said locking tabs 501 rest in the rest position on a radial shoulder 710 (better visible in FIGS. 4 and 7) of said well of valve 700. This radial shoulder 710 is preferably inclined downwards and radially outwards, forming an angle γ with the longitudinal central axis X of the valve 200, so that when the reservoir 100 slides axially in the body 10 when actuated, said axial locking tabs 501 slide on said inclined shoulder 710, which deforms radially outwardly. Advantageously, this angle is greater than 20 °, preferably greater than 30 °, and of course less than 90 °.

A trigger element 600 is mounted to slide axially around said valve well 700 between a locking position, in which it blocks said locking element 500 in its non-actuating position, and a release position, in which it no longer blocks said element. in particular, said trigger element 600, in the locked position, cooperates with said locking tabs 501, preventing any radially outward deformation of said locking tabs 501. Thus, when said trigger element 600 is in the position of blocking, it prevents the radially outward deformation of said locking tabs 501, which consequently remain axially blocked by said shoulder 710 of the valve well 700, which blocks the axial displacement of the reservoir 100 and thus the actuation of the valve 200. Advantageously, the surface 610 of the trigger element 600, which cooperates with said blocking tabs 501 in the locked position, is inclined and forms an angle x with the longitudinal central axis X of the valve 200, as shown in Figure 7. This angle x is preferably less than 30 °, preferably less than 15 °.

According to the required specifications, the x and y angles can be optimized to facilitate actuation of the triggering system controlled by inhalation.

Trigger element 600 is connected to said inhalation-controlled triggering system, in particular to said inhalation-responsive member 60, so that when the latter deforms and / or moves, it causes said trigger element 600 to turn on. its blocking position to its release position. In the locked position, the trigger element 600 advantageously cooperates substantially sealingly with the outside of the valve well 700, to mobilize most of the inhalation flow to the actuation of the triggering system controlled by inhalation. When the trigger element 600 leaves its blocking position and goes to its release position, it opens an air passage around said valve well, as can be seen in FIGS. 5 and 6. This promotes inhalation by generating a call of air, thus improving the efficiency of the dose-taking. Likewise, this air intake makes the inhalation process more comfortable for the user

The trigger element 600 is advantageously fixed to an outer sleeve 650 forming a cover and which slides axially outside the body 10. This cover 650 cooperates with an opening 13 to substantially open this opening 13 in the locking position, and for substantially close this opening 13 in the release position. This opening 13 being open at the beginning of inhalation, it allows a reliable actuation of the triggering system by inhalation, in particular the organ sensitive to inhalation 60, avoiding any depression outside of said sensitive body. inhalation 60 when deformed. This optimizes this triggering by inhalation. When the trigger element 600 has moved axially towards its release position under the effect of inhalation, and therefore when the metering valve 200 can be actuated to dispense a dose of fluid, the lid 650 closes the opening 13.

Advantageously, said cover 650 is accessible from the outside. This makes it possible, in case of necessity, to manually move the trigger element 600 so as to be able to actuate the metering valve 200 even without inhalation, for example if the person to receive the dose of fluid product is incapable of producing a sufficient inhalation. It is therefore a security.

The organ sensitive to inhalation 60 is advantageously designed as a deformable air chamber. Advantageously, this air chamber comprises a deformable membrane which is connected on the one hand to the body 10 and on the other hand to said trigger element 600. Upon inhalation, the deformable membrane of the inhaled organ 60 deforms and / or contracts under the effect of the depression generated by inhalation, causing the trigger 600 to move locking position to its release position. This then allows the radial deformation of said locking tabs 501 and thus the displacement of said locking member 500 from its non-actuating position to its actuating position. The figures show a deformable membrane made in the form of a pocket or a diaphragm, but said membrane could be made differently, for example in the form of a bellows Of course, other forms are also conceivable.

The valve 200 is therefore actuated at the time of inhalation, so that the fluid dose is expelled out of the dispensing orifice simultaneously with the inhalation.

When the user wishes to use the device, he places the mouthpiece 400 in his mouth, and manually presses the actuator 20. The latter can then slide axially around the reservoir 100 between its rest positions and loaded to load the spring 21, until the actuator 20 abuts with the body 10, as shown in Figure 2. The compressed spring 21 exerts an axial force on the reservoir 100 via said proximal wall 22, said reservoir 100 is blocked and prevented from sliding in the body 10 by the locking tabs 501 of the blocking element 500, which rest on the shoulder 710 of the valve well 700. Optionally, the reservoir 100 can perform a small initial axial stroke before being blocked, this small initial stroke is however insufficient to actuate the metering valve 200. Figure 1 shows the device at rest and Figure 2 shows the device in the locking position of the res tank 100, after loading the actuator 20 and before inhalation.

When the user inhales through the mouthpiece 400, it will deform the inhalation sensitive member 60, which will slide the trigger element 600 attached to said inhalation sensitive member 60, as visible on the FIG. 4. This displacement of the trigger element 600 on the valve well 700 will radially release the tabs 501 of the blocking element. 500. Under the effect of the axial force transmitted by the spring 21 of the actuator 20 to the tank 100, the axial tabs 501 will be able to deform radially outward, and thus pass over said shoulder 710, to allow the sliding of the reservoir 100 to its dispensing position, and therefore the actuation of the valve 200. This dispensing position is shown in FIG. 6.

At the end of inhalation, the trigger element 600 is brought upwards by the elasticity of the membrane of the inhalation-sensitive organ 60. If necessary, the triggering element can also be brought manually to the rest position. , by sliding the cover 650 axially upwards.

When the user releases his pressure on the actuator 20, the tank 100 returns towards the rest position under the effect of the return spring of the valve 200, and simultaneously the valve 210 of the metering valve returns to the position of rest, loading a new dose of fluid into the valve chamber. In parallel, the actuator 20 also returns to the rest position under the effect of the spring 21. The device is then ready for another use.

It should be noted that with the actuator 20, the device can also be actuated correctly if the user inhales before pressing the actuator. Nevertheless, to optimize the synchronization of the dose distribution with the inhalation, it is preferable that the actuator 20 is in the loaded position at the moment the user begins its inhalation.

The present invention is particularly applicable for the treatment of asthma attacks or COPD (Broncho Obstructive Pulmonary Disease) in use with formulations of the type salbutamol, aclidinium, formoterol, tiotropium, budesonide, fluticasone, indacaterol, glycopyrronium, salmeterol, umeclidinium bromide, vilanterol, olodaterol, striverdi, or any combination of these formulations.

The present invention has been described with reference to an advantageous embodiment, but it is understood that one skilled in the art can make any modifications, without departing from the scope of the present invention as defined by the appended claims.

Claims

claims

1 .- fluid dispensing device synchronized with inhalation, comprising a body (10) provided with a mouthpiece (400), a product reservoir (100) containing a fluid and a propellant being mounted axially sliding in said body (10), a metering valve (200) having a valve (210) being assembled on said reservoir (100) to selectively dispense the fluid, said device comprising:

a blocking element (500) displaceable and / or deformable between a non-actuating position, in which said metering valve (200) can not be actuated, and an actuating position, in which said metering valve (200) can being actuated, said locking element (500), in non-actuating position, cooperating on the one hand with the body (10) and on the other hand with the reservoir (100) to prevent axial displacement of said reservoir (100) in the body (10), and

an inhalation-controlled triggering system comprising an inhalation sensitive member (60) which is deformable and / or displaceable by inhalation, said inhaled sensitive member (60), when deforms and / or moves, displacing and / or deforming said actuating element (500) from its non-actuating position to its actuating position,

characterized in that said device comprises an actuator (20) fixed on said reservoir (100), said actuator (20) having a proximal wall (22) fixed, in particular force-fitted, on the bottom of the reservoir (100), a body (23) sliding axially about said proximal wall (22), and a spring (21) disposed between said proximal wall (22) and a distal wall (24) of said body (23), said body (23) sliding axially about said proximal wall (22) between a resting position and a loaded position, wherein said spring (21) is compressed, such that after actuation of said inhalation controlled triggering system, said compressed spring (21) axially displacing said reservoir (100) in said body (10) to actuate said metering valve (200).

2.- Device according to claim 1, wherein said locking element (500) is a fixed locking ring, in particular latched, on said reservoir (100) and having at least one axial lug (501), including three cooperating with a shoulder (710) integral with said body (10) to block the axial displacement of said reservoir (100) in said body (10).

3.- Device according to claim 2, wherein said at least one axial tab (501) is deformable radially outwardly to move from the non-actuating position to the actuating position, a trigger element (600) being provided to maintain said at least one axial lug (501) in the non-actuating position.

4.- Device according to claim 3, wherein said trigger element (600) is movably mounted between a locking position, in which it blocks said locking element (500) in its non-actuating position, and a release position, wherein it does not block said locking member (500).

5.- Device according to claim 4, wherein said member responsive to inhalation (60) of said triggering system controlled by inhalation comprises a deformable membrane defining a deformable air chamber, said deformable membrane being fixed to said trigger element (600), said deformable membrane being deformed upon inhalation so that it moves said trigger member (600) from its locking position to its release position.

6.- Device according to any one of the preceding claims, wherein said spring (21) is a coil spring.

7.- Device according to any one of claims 1 to 5, wherein said spring (21) is a plastic spring.

8.- Device according to any one of claims 1 to 5, wherein said spring (21) is a foam member.

9.- Device according to any one of the preceding claims, wherein said actuator (20) comprises a radial flange (25) extending radially outwardly on either side of said body (23).

10.- Device according to any one of the preceding claims, wherein the rest position of said actuator (20) is defined by an axial abutment formed between a lower axial edge (29) of said proximal wall (22) and a radial shoulder internal (26) of said body (23).

Apparatus according to any one of the preceding claims, wherein the loaded position of said actuator (20) is defined by an axial abutment formed between a lower axial edge (27) of said body (23) and an upper axial edge (801 ) an inner sleeve (800) integral with said body (10).